Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

University Medical Centre Ljubljana

Status

Completed

Conditions

Atrial Fibrillation

Shock

Perioperative/Postoperative Complications

Multiple Trauma

Treatments

Device: Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)

Study type

Observational

Funder types

Other

Identifiers

NCT01373996

HMW10

Details and patient eligibility

About

The purpose of this study is to determine whether wireless transmission of invasive arterial blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor is feasible, safe and as accurate as conventional cable connection.

Full description

The technology for invasive arterial blood pressure measurement in emergency room, operating theater, recovery room and intensive care unit is well established and uses pressure sensor connected via cable to patient's bedside monitor. The wireless sensors result in reduction of wires attached to the patient and may enhance nursing, treatment and transportation of patients in aforementioned setting.

The HMW 10 Wireless System was developed and incorporates wireless transmission of patient's signal. The purpose of the study was to measure the quality of data transmitted through the HMW 10 Wireless System, and to demonstrate that the quality of the data meets the requirements of European Directive 93/42/EEC (Medical Device Directive - MDD) and EN/IEC 60601-1 and EN/IEC 60601-2-34.

Enrollment

12 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria